Cy azofamid Dietary Exposure and Risk Assessment DP Number: 371163

PC Code: 085651

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### UNITED STATES ENVIRONMENTA L PROTECTION A GENCY WA SHINGTON, D.C. 20460

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBS TANCES 

### MEMORANDUM DATE: March 8 , 20 1 0 SUBJECT: Cyazofamid : Acute and Chronic Aggregate Dietary (Food and Drinking Water)

Exposure and Risk Assessment s for Tolerance Petition and Proposed Section 3 Amendment Registration for Uses on Brassica (C ole) Leafy Vegetables Crop Group 5, Turnip Greens, Spinach, and Hops. PC Code: 085651 DP Barcode: 371163 Decision No.: 420982 Registration No. : 71512 - 2 , 71512 - 3 Petition No.: 9E7615 Regulatory Action: Sec. 3 Registration Risk Assessment Type: N A Case No.: NA T XR No.: NA CAS No.: 120116 - 88 - 3 MRID No.: 40 CFR: 180.601 

### REVI EWER: Amelia M. Acierto, Chemist

R isk Assessment Branch 3 Health Effects Division (7509P ) THROUGH: Mohsen Sahafey an, Chemist

Thurston Morton , Chemist Dietary E xposure Science Advisory Council (DESAC) Health Effects Division (7509P ) and Stephen Funk, Senior Science Advisor Risk Assessment Branch III Health Effects Division (7509P ) TO: Nancy

Tsaur , Risk Assessor R isk Assessment Branch III Health Effects Div ision (7509P ) and Barbara Madden, RM #5 Risk Integration, Minor Use, and Emergency Response Branch Registration Division (7505P)Cy azofamid Dietary Exposure and Risk Assessment DP Number: 371163

PC Code: 085651

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### Executive Summary A cute ( females 13 - 49 y ears old only) and chronic dietary (food and drinking water) exposure and risk as sessments were conducted using the Dietary Exposure Evaluat ion Model (DEEM FCIDTM), Version 2.03, which use s food consumption data from the U.S. Department of Agriculture’s Continuing Survey s of Food Intakes by Individuals (CSFII) from 1994 - 1996 and 1998. Dietary

risk assessments w ere performed to support a FIFRA Section 3 request to amend the registration of the fungicide cy azofamid for use on Brassica (Cole) leafy v egetables c rop group 5, turnip g reens, spinach, and h ops . Acute and chronic dietary (drinking water) risk assessment for cy azofamid have been c onduc ted previously for turf and ornamentals (D 332427, Susan L . Stanton, 9/14/06 ) . The risk estimate considered drinking water exposure only . Subsequent dietary risk assessments were performed to support separate FIFRA Section 3 requests on carrots (D381623, A.M.Acierto, 3/5/2008) and on fruiting vegetables, okra, and grapes (D357043, Amelia M. Acierto 3/25/09). Dietary risk estimates were determined considering exposures f r om food plus drinking water using the upper bound estimated drinking water concentrati ons (EDWCs) for cy azofamid in surface water sources for turf grass provided by the Environmental Fate and Effects Division (EFED). This decision was based on EFED’s determination that the highest use rate per application per season is on turf grass as compared with the use rates on various food crops (D342613, Mohammed A. Ruhman, 2/21/08 and D356836, Jose L . Melendez, 3/24/09 ). Additional runs to cover the new crops ( B rassica (Cole) leafy

v egetables c rop group 5, turnip greens, spinach, and h ops ) were per formed b y EFED with the same result that the highest EDWCs of all crops (past and present) were obtained for turf and ornamentals (surface waters) and ornamentals (ground water) ( D370673, Jose L . Melendez, 3/ 1 /20 10). As in the earlier dietary assessments, HED used the highest calculated screening EDWCs for surface water based on the 3 rd 

### modeling scenario: 136 ppb for the acute analy sis and 133 ppb for the chronic anal ys is. As noted previously , this approach may

significantly

overestimate dietary

exposure to cy azofamid from drinking water; however, since estimated aggregate food and drinking water exposures using this approach are well below the acute and chronic levels of concern, additional refinements were not deemed necessary . For both the acute and chronic analy ses, the drinking water EDWC was incorporated directly as a point estimate in the DEEM anal ys is to assess exposure to cy azofamid from drinking water. Drinking water was incorporated directl y into the DEEM - FCID into the food categories “water, d irect, all sources” and water, indirect, all sources. The acute dietary

(food plus drinking water) anal ysis was performed for females 13 - 49 y ears old only since an acute endpoint of concern was not identified for the general U.S. population. The chroni c dietary anal ys es were performed for the general U.S. population and all the population subgroups. HED is concerned when estimated dietary risks exceed 100% of the acute or chronic population adjusted dose (aPAD and cPAD). The acute and chronic anal ys es assumed that cy azofamid residues are present in all registered food commodities at tolerance levels and that 100% of all commodities are assumed treated. P rocessing factors for all registered or proposed crops were set to 1, based on the results ofCy azofamid Dietary Exposure and Risk Assessment DP Number: 371163

PC Code: 085651

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### p rocessing studies demonstrating that residues of cy azofamid in processed commoditi es would not exceed the raw agricultural commodity (RAC) tolerances. Acute Dietary

Expos ure Results The unrefined acute dietary (food + water) exposure assessment was perfo rmed for females 13 - 49 ye ars old onl y , since an acute endpoint of concern was not identified for the general U.S. population . Based on the assumptions described above, acute dietary exposure of females 13 - 49 ye ars old is well below HED’s level of conc ern at the 95 th 

### percentile of exposure. Combined d ietary exposure from food and drinking water is estimated at 0.0 12 139 mg/kg/day , equivalent to 1 .2 % of the acute Population Adjusted Dose ( aPAD ) . Chronic Dietary

Exposure Results C hronic dietary

exposure e stimates for food and drinking water combined are also well below HED’s level of concern. Using the DEEM - FCID software, dietary exposure for the general U.S. population is estimated at 0.00 4 9 45 mg/kg/day , equivalent to <1% of the chronic Population Adjust ed Dose ( cPAD ) and 0.01 1 07 9 mg/kg/day , equivalent to 1.2 % of the cPAD for infants <1 ye ar old , the population subgroup with the highest estimated chronic dietary exposure to cy azofamid . I. Introduction Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects). This dose is referre d to as the population adjusted dose (PAD). The PAD is equivalent to the reference dose (RfD) divided by the special Food Quality Protection Act (FQPA) Safet y Factor. For acute and non - cancer chronic exposures, HED is concerned when estimated dietary ris k exceeds 100% of the PAD. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 6/21/2000, web link: http://www.epa.gov/fedrgstr/EPA - PEST/2000/July /Day - 12/6061.pdf ; or see SOP 99.6 (8/20/99). The most recent HED dietary risk assessment for cy azofamid ( D3 57043 , Amelia M. Aci erto, 3/2 5/0 9 ) was conducted t o support the FIFRA §3 registration on fruiting vegetables, okra and grapes . As in the 2009 dietary assessment , this current assessment incorporates drinking water directly into the dietary

analy ses . II. Food Residue Informa tion Residues of Concern: The HED Metabolism Assessment Review Committee (MARC) c oncluded in a meeting on 2/18/ 04 that for the risk assessment and tolerance expression, parent and the metabolite designated as CCIM are the residues of concern for plant co mmodities. The MARC also concluded that cyazofamid and the metabolites designated as CCIM, CCIM - AM andCy azofamid Dietary Exposure and Risk Assessment DP Number: 371163

PC Code: 085651

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### CTCA are considered to be the major residues in water and should be included in the drinking water risk assessment. The current uses of cy azofamid fall under 40 CFR §180.6(a)(3) (i.e., there is no reasonable expectation of finite residues in livestock commodities). Tolerances: T olerances have bee n established under 40 CFR §180.601 for the combined residues of cy azofamid and its metabolite CCIM [4 - ch loro - 5 - (4 - methylphenyl) - 1H - imidazole - 2 - carbonitrile] in or on cucurbit vegetables , Group 9 (0.1 ppm) ; vegetable, fruiting, group 8 (0.40 ppm); potato (0.02 ppm) ; okra (0.40 ppm), carrot, roots (0.09 ppm) and grapes (1.5 ppm) . T urf and ornamentals (non - foo d use sites) did not require establishment of additional tolerances. Residue Data used for the Acute and Chronic Assessment s : The unrefined acute and chronic anal ys es assumed that cyazofamid residues are present in/on all registered food commodities at t olerance levels and assumed 1 00% of all commodities are treated. There are no processing data for b rassica (Cole) leafy

vegetables crop group 5, turnip greens, spinach, and hops . The tolerance summary

for cy azofamid used i n the acute and chronic anal ys es for the proposed new uses are summarized below in Table 1. A complete listing of the residues used in the anal ys es are included in Attachments 1, and 3.
Table 1. Tolerance Summary for Cyazofamid Proposed Uses on Brassica Cole Leafy Vegetables Crop Gr oup 5, Turnip Greens, Spinach and Hops. Comm odity Proposed Tolerance (ppm) Recommended

Tolerances (ppm) Tolerances Proposed under 40 CFR§180.601 Brassica Head and Stem Subgroup 5A 1.2 1.2 1.2 Brassica Leafy Greens Subgroup 5B 12.0 12.0 12.0 Turnip gree ns 12.0 12.0 12.0 Spinach 9.0 9.0 9.0 Hops 10.0 10.0 10.0 

### III. Drinking Water Data Reference: Estimated Drinking Water Concentrations of Parent Cyazofamid and its Degradates of Concern CCIM, CCIM - AM and CTCA, for Use in Human Health Risk Assessment: New U ses on Brassica (Cole) Leafy Vegetables & Turnip Greens (Crop Group 5), Spinach, and Hops ; Jose L . Melendez, D3 70673 , March 1, 2010. Th e above memorandum from EFED is a drinking waters assessment (DWA) that presents the EDWCs for parent cy azofamid, and th e degradates CCIM, CCIM - AM and CTCA for use in an FQPA human health risk assessment. Cy azofamid fungicide and/or its degradates may reach both surface and groundwater under some conditions. The degradates’ EDWCs were modeled individually

(as opposed to th e use of the total residue approach). This was done because sufficient data were available on the degradates to model them individually (although some assumptions were made, see below). Itis noted that DWAs were previously issued as follows :Cy azofamid Dietary Exposure and Risk Assessment DP Number: 371163

PC Code: 085651

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5 Summary o f Cyazofam id Drinking Water Exposure Assessments Date DP Barcode Uses included 4/28/04 301099 Cucurbits, potatoes and tomatoes 9/6/06 319466 Turf and Ornamentals 3/5/08 342613 Carrots 3/24/09 35683 6 Fruiting vegetables + okra, and grapes (East of the Rocky mountains) 

### This DWA builds largel y upon the previous assessments. Additional runs were performed to cover the new crops; the highest EDWCs of all crops (past and present) were obtained for turf and ornamentals (surface waters) and ornamentals (gro und water). The screening - level surface water and ground water EDWCs were obtained using the tier 2 linked aquatic models PRZM/ EXAMS and the tier 1 aquatic model SCI - GROW, respectivel y. EDWCs are summarized in Table 2 for three scenarios as follows:

 1 s t 

### scenario: the parent is applied at the maximum rate;  2 nd 

### scenario: the degradates CCIM and CCIM - AM (and CTCA) are applied at the parent molar equivalent amounts, spreading the application rate through the degradates, according to the molecular ratios and the adjusted maximum percentages of the degradates observed in the environmental fate studies; and  3 rd 

### scenario: the terminal degradate, CTCA, is applied assuming application of 100% molar conversion of the parent to the degradate. Based on the results p resented in Table 2 below and a time - line of exposure, the surface water acute EDWC is 38.2 ppb (equal to the Parent “14.362 ppb” + CCIM “17.106 ppb” + CCIM - AM “6.699 ppb”). CTCA is not included in the surface water acute EDWC because it is not expected t o be present in this time frame. The surface water non - cancer chronic is 133.5 ppb and the cancer chronic is 77.3 ppb (equal to the value for the terminal degradate, CTCA). For ground water, the EDWC is 2.18 ppb, which is suitable for acute and chronic exp osures (equal to the value for the terminal degradate, CTCA). Table 2 . M axima of surface and ground water EDWCs for cyazofam id and its relevant ma jor degradates. Turf and ornamentals use pattern, previously reported in D319466 (dated 9/6/06) .
Scenario C

hem ical Surface water EDWCs (ppb) Ground water EDWC (ppb) Acute Chronic “ N on Cancer” Chronic

“Cancer” 1 st Scenario Cy azofamid 14.362 0.377 0.279 0.01180 2 nd Scenario CCIM 17.106 12.094 10.600 0.00061

CCIM - AM 6.699 6.312 3.611 0.00270 3 rd Scenar io CTCA 136.242 133.458 77.270 2.180

EDWCs 38.2 133.5 77.3 2.18 

### The above stated values represent upper - bound estimates of the parent, individual degradates and/or terminal degradate concentrations that might be found in surf ace water and groundwater due to the use of cy azofamid on turf and ornamentals . EFED emphasizes that this is a screening level anal ys is and additional refinements c ould be made if needed.Cy azofamid Dietary Exposure Assessment DP Number: 343442 PC Code: 085651

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### Ty pically , HED uses the higher of the surface or groundwater estim ates for each duration when assessing dietary

risk. Therefore, a lthough CTCA is not expected to be found in the acute time frame of exposure , HED will continue to use the EDWC which includes CTCA (136 ppb) . This approach may

significantly

overestimate die tary

exposure to cy azofamid from drinking wate r, however, since estimated aggregate food and drinking water exposures using this approach are well below the acute and chronic levels of concern, additional refinements were not deemed necessary . IV. DEE M - FCIDTM Program and Consumption Information Cy azofamid acute and chronic d ietary exposure assessment s were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM FCIDTM, Version 2.03 ), which incorporate s consumption data from USDA’s Continuing Survey s of Food Intakes b y Individuals (CSFII), 1994 - 1996 and 1998. The 1994 - 96, 98 data are based on the reported consumption of more than 20,000 individuals over two non - consecutive survey day s. Foods “as consumed” (e.g., apple pie) are linked to EPA - defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly

available recipe translation files developed jointly by USDA/ARS and EP A. For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events. Based on anal ys is of the 1994 - 96, 98 CSFII consumption data, which took into account dietary

patterns and survey

respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 ye ar old), children 1 - 2, childr en 3 - 5, children 6 - 12, youth 13 - 19, adults 20 - 49, females 13 - 49, and adults 50+ years old. For chronic dietary

exposure assessment s , an estimate of the residue level in each food or food form (e.g., orange or orange juice) on the food commodity residue li st is multiplied by the average dail y consumption estimate for that food/food form to produce a residue intake estimate. The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food form s on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/kg bod y weight/day and as a percent of the cPAD. This procedure is performed for each population subgroup. For acute exposure assessments, ind ividual one - day food consumption data are used on an individual - by - individual basis. The reported consumption amounts of each food item can be multiplied by

a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., onl y those who reporte d eating relevant commodities/food forms) and a per - capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for all tier s of anal ysis. However, for Tier s 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.Cy azofamid Dietary Exposure Assessment DP Number: 343442 PC Code: 085651

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### V. Toxicological Information The toxicology

database for cy azofamid with regard to the acute an d chronic reference doses (RfDs) remain unchanged. The rationale for toxicity endpoint selection was discussed in detail in the most recent human health risk assessment document (D356837, N. Tsaur, 5/5/20009) and will not be repeated here. However, the d oses and toxicological endpoints selected for dietary risk assessments are summarized in Table 3.

. Table 3 . Summary of Cyazofam id Toxicological Dose s and Endpoints for Dietary Risk Assessment . Exposure Scenario Dose Used in Risk

Assessment, UF FQ PA SF and Level of Concern for Risk Assessment Study and Toxicological Effects
Ac ute Dietary (Fem ales 13 - 49 years of age) NOAEL = 100 mg/kg

UF = 100 Acute RfD = 1.0 mg/kg FQPA SF = 1X aPAD = acute RfD FQPA SF
= 1.0 mg/kg Rat Prenatal D evelopmental Toxicity (MRID 45408933) LOAEL = 1,000 mg/kg based on developmental toxicity findings of increased incidence of bent ribs. Ac ute Dietary (General population including infants and children) NOAEL = NA

UF = NA Acute RfD = NA FQPA SF = NA aPAD = acute RfD FQPA SF = NA No adverse effects were observed which could be attributed to a single - dose exposure. Chronic Dietary (All populations) NOAEL= 94.8

mg/kg/day UF = 100 Chronic RfD = 0.95 mg/kg/day FQPA SF = 1X cPAD = chroni c RfD FQPA SF = 0.95 mg/kg/day 18 - Month Mouse Oral Carcinogenicity (MRID 45408932) LOAEL = 985 mg/kg/day based on increased skin lesions. UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no - observed - adverse - effect - le vel, LOAEL = lowest - observed - adverse - effect - level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, NA = Not Applicable 

### VI. Results/Discussion As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM - FCIDTM anal ys es estimate the dietary exposure of the U.S. population and various population subgroups. The acute exposure results are reported in Tables 4 for females 13 - 49 onl y. The chronic results reported in Ta ble 5 are for the general U.S. Population, all infants (<1 y ear old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, females 13 - 49, adults 20 - 49, and adults 50+ years. Results of Acute Dietary

Exposure Analy sis The Tier 1 acute dietary (food + drinking water) exposure assessment was performed for females 13 - 49 y ears old onl y, since an acute endpoint of concern was not identified for the generalCy azofamid Dietary Exposure Assessment DP Number: 343442 PC Code: 085651

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### population. Based on the assumptions described above in sections II and III, acute dietary exposure of females 13 - 49 ye ars old is well below HED’s level of concern (i.e., <100% of the aPAD of 1.0 mg/kg). The combined d ietary exposure from food and drinking water is estimated at 0.0 12139 mg/kg/day

( equivalent to 1.2 % of the aPAD ) , at the 95 th 

### percentile of exposure , the appropriate regulatory

statistic for Tier 1 dietary assessments as shown in Table 4 . Table 4 . Results of Acute Die tary Exposure Analysis for Food and Drinking Water at the 95 th Percentile of Exposure us ing DEEM FCID Population Subgro up aPAD

(m g/kg/day) 95 th Percentile 99th Percentile 99.9th Percentile

Exposure (m g/kg/day) % aPAD Exposure (m g/kg/day) % aPAD Exposure (m g/kg/day) % aPAD Fem ales 13 - 49 years old 1 0.0 12 139 1 .2 0.0 2 4480 2. 4 5 0.0 5 9 739 5.9 7 

### Results of Chronic Dietary Exposure Analysis Cy azofamid chronic dietary (food + water) exposure estimates using the DEEM - FCIDTM software are well below HED’s level of concern for the general U.S. population and each of the population subgroups. Dietary exposure was estimated at 0.00 4 9 45 mg/kg/day for the U.S. population ( <1 % of the cPAD) and 0.0 1 1 07 9 mg/kg/day ( 1. 2 % of the cPAD) for the most highly exposed population subgroup ( infants <1 ye ar old ). The estimated exposures/risks for food and drinking water are summarized in Table 5 for all populations .

Table 5 . Results of Chronic Dietary Exposure Analysis for Food and Dri nking Water Population Subgroup Exposure (mg/kg/day) % cPAD General U.S. Population 0 .004 945 <1 All Infants (< 1 year old) 1 0.01 1 079 1 .2 Children 1 - 2 y ears old 0.0 1 0 7 49 1 Children 3 - 5 y ears old 0.00 8 5 56 <1 Children 6 - 12 y ears old 0.00 4 916 <1 Youth 13 - 19 y ears old 0.00 3 3 93 <1 Adults 20 - 49 y ears old 0.00 4 3 51 <1 Adults 50+ years old 0.00 48 84 <1 Fem ales 13 - 49 y ears old 0.00 4 30 2 <1 1 The population subgroup with the highest estimated chronic dietary (food + drinking water) exposure and risk is indicated by bold text.Cy azofamid Dietary Exposure Assessment DP Number: 343442 PC Code: 085651

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### VII. Characterization of Inputs/Outputs These acute and chronic di etary exposure and risk estimates are conservative since they assume that 100% of crops are treated with cy azofamid and that residues are present at toleranc e levels. In addition, drinking water exposure estimates were based on screening level estimates generated by the PRZM - EXAMS model. Dietary exposure estimates could be refined through the use of anticipated residues and percent crop treated data, as well as refined estimated drinking water concentrations. However, since estimated exposures and risks using conservative assumptions are well below HED’s level of concern, such refinement is not warranted. VIII. Conclusions These unrefined, Tier 1 dietary e xposure anal ys es using DEEM - FCIDTM indicate that acute and chronic dietary

exposure s to cy azofamid from food and drinking water are well below HED’s level of concern for this pesticide. The e stimated acute exposure of females 13 - 49 ye ars old, the only popu lation subgroup of concern for acute exposure, represents 1 .2 % of the aPAD at the 95 th 

### percentile of exposure. Estimated chronic dietary exposures are less than or equal to 1.2 % of the cPAD for the general U.S. population and all population subgroups. IX . List of Attachments

Acute Food + Drinking Water Input File Acute Food + Drinking Water Results File Chronic Food + Drinking Water Input File Chronic Food + Drinking Water Results FileCy azofamid Dietary Exposure Assessment DP Number: 343442 PC Code: 085651

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## Chronic Food + Drinking Water Input File U .S. Environmental Protection Agency Ver. 2.00 DEEM - FCID Chronic analysis for CYAZOFAMID 1994 - 98 data Residue file: C: \ Documents and Settings \ aacierto \ Desktop \ DEEM - FCID Files \ DEEM2010 \ Chronic cyazofamid food+wate r.R98 Adjust. #2 NOT used Analysis Date 03 - 16 - 2010 Residue file dated: 03 - 16 - 2010/13:48:52/8 Reference dose (RfD) = 0.95 (NOEL) = 94.8 mg/kg bw/day Comment:Drinking Water using CTCA Drinking Water estimate (scenario #3)

-- -------------------------------------------------------------------------- Food Crop Residue Adj.Factors Comment EPA Code Grp Food Name (ppm) #1 #2

-------- ---- ------------------------------- ---------- ------ ------ 09020210 9B Balsam pear 0.100000 1.000 1.000 05010610 5A Broccoli 1. 200000 1.000 1.000 05010611 5A Broccoli - babyfood 1.200000 1.000 1.000 05010620 5A Broccoli, Chinese 1.200000 1.000 1.000 05020630 5B Broccoli raab 12.000000 1.000 1.000 05010640 5A Brussels sprouts 1.200000 1.000 1.000 05010690 5A Cabbage 1.200000 1.000 1.000 05020700 5B Cabbage, Chinese, bok choy 12.000000 1.000 1.000 050 10710 5A Cabbage, Chinese, napa 1.200000 1.000 1.000 05010720 5A Cabbage, Chinese, mustard 1.200000 1.000 1.000 09010750 9A Cantaloupe 0.100000 1.000 1.000 01010780 1AB Carro t 0.090000 1.000 1.000 01010781 1AB Carrot - babyfood 0.090000 1.000 1.000 09010800 9A Casaba 0.100000 1.000 1.000 05010830 5A Cauliflower 1.200000 1.000 1.000 09020880 9B Chayote, fruit 0.100000 1.000 1.000 09021020 9B Chinese waxgourd 0.100000 1.000 1.000 05021170 5B Collards 12. 000000 1.000 1.000 09021350 9B Cucumber 0.100000 1.000 1.000 95001750 O Grape 1.500000 1.000 1.000 95001760 O Grape, juice 1.500000 1.000 1.000 95001761 O Grape, juice - babyfood 1.500000 1.000 1.000 95001770 O Grape, leaves 1.500000 1.000 1.000 95001780 O Grape, raisin 1.500000 1.000 1.000 950 01790 O Grape, wine and sherry 1.500000 1.000 1.000 09011870 9A Honeydew melon 0.100000 1.000 1.000 95001880 O Hop 10.000000 1.000 1.000 05021940 5B Kale 12.000000 1.000 1.000 05011960 5A Kohlrabi 1.200000 1.000 1.000 05022290 5B Mustard greens 12.000000 1.000 1.000 08002340 8 Okra 0.400000 1.000 1.000 08002700 8 Pepper, bell 0.400000 1.000 1.000 08002701 8 Pepper, bell - babyfood 0.400000 1.000 1.000 08002710 8 Pepper, bell, dried 0. 400000 1.000 1.000 08002711 8 Pepper, bell, dried - babyfood 0.400000 1.000 1.000 08002720 8 Pepper, nonbell 0.400000 1.000 1.000 08002721 8 Pepper, nonbell - babyfood 0.400000 1.000 1.000 08002730 8 Pepper, nonbell, dried 0.400000 1.000 1.000 01032960 1C Potato, chips 0.020000 1.000 1.000 01032970 1C Potato, dry (granules/ flakes) 0.020000 1.000 1.000Cy azofamid Dietary Exposure Assessment DP Number: 343442 PC Code: 085651

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Page 11 of 16 010 32971 1C Potato, dry (granules/ flakes)
- b 0.020000 1.000 1.000 01032980 1C Potato, flour 0.020000 1.000 1.000 01032981 1C Potato, flour - babyfood 0.020000 1.000 1.000 01032990 1C Potat o, tuber, w/peel 0.020000 1.000 1.000 01032991 1C Potato, tuber, w/peel
- babyfood 0.020000 1.000 1.000 01033000 1C Potato, tuber, w/o peel 0.020000 1.000 1.000 01033001 1C Potato, tuber, w/o pe el - babyfood 0.020000 1.000 1.000 09023080 9B Pumpkin 0.100000 1.000 1.000 09023090 9B Pumpkin, seed 0.100000 1.000 1.000 05023180 5B Rape greens 12. 000000 1.000 1.000 04013550 4A Spinach 9.000000 1.000 1.000 09023560 9B Squash, summer 0.100000 1.000 1.000 09023561 9B Squash, summer - babyfood 0.100000 1.000 1.000 09023570 9B Squash, winter 0.100000 1.000 1.000 09023571 9B Squash, winter - babyfood 0.100000 1.000 1.000 08003740 8 Tomatillo 0.400000 1.000 1.000 080 03750 8 Tomato 0.400000 1.000 1.000 08003751 8 Tomato - babyfood 0.400000 1.000 1.000 08003760 8 Tomato, paste 0.400000 1.000 1.000 08003761 8 Tomat o, paste - babyfood 0.400000 1.000 1.000 08003770 8 Tomato, puree 0.400000 1.000 1.000 08003771 8 Tomato, puree - babyfood 0.400000 1.000 1.000 08003780 8 Tomato, dried 0.400000 1.000 1.000 08003781 8 Tomato, dried - babyfood 0.400000 1.000 1.000 08003790 8 Tomato, juice 0.400000 1.000 1.000 95003800 O Tomato, Tree 0. 200000 1.000 1.000 05023890 5B Turnip, greens 12.000000 1.000 1.000 86010000 O Water, direct, all sources 0.133000 1.000 1.000 86020000 O Water, indirect, all sources 0.133000 1.000 1.000 09013990 9A Watermelon 0.100000 1.000 1.000 09014000 9A Watermelon, juice 0.100000 1.000 1.000Cy azofamid Dietary Exposure Assessment DP Number: 343442 PC Code: 085651

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## Chronic Food + Drinking Water Results File U.S. Environmental Protection Agency Ver. 2.00 DEEM - FCID Chronic analysis for CYAZOFAMID (1994 - 98 data) Residue file name: C: \ Documents and Settings \ aacierto \ Desktop \ DEEM - FCID Files \ DEEM2010 \ Chronic cyazofamid food+water.R 98 Adjustment factor #2 NOT used. Anal ysis Date 03 - 16 - 2010/13:52:31 Residue file dated: 03 - 16 - 2010/13:48:52/8 Reference dose (RfD, Chronic) = .95 mg/kg bw/day NOEL (Chronic) = 94.8 mg/kg bw/day COMMENT 1: Drink ing Water using CTCA Drinking Water estimate (scenario #3)

============================================================================= Total exposure by population subgroup

------------------------------------------------------------- ---------------- Total Exposure

----------------------------------- Population mg/kg Margin of Percent Subgro up body wt/day Exposure 1/ of RfD

-------------------------------------- ------------- ---------- --------- U.S. Population (total) 0.004945 19,170 0.5% U.S. Population (spring season) 0.004835 19,607 0.5% U.S. Population (summer season) 0.005231 18,123 0.6% U.S. Population (autumn season) 0.004869 19,469 0.5% U.S. Population (winter season) 0.004838 19 ,595 0.5% Northeast region 0.004930 19,231 0.5% Midwest region 0.004722 20,075 0.5% Southern region 0.004802 19,743 0.5% West ern region 0.005426 17,470 0.6% Hispanics 0.004836 19,603 0.5% Non - hispanic whites 0.004649 20,390 0.5% Non - hispanic blacks 0.006007 15,781 0.6% Non - hisp/non
- white/non
- black 0.007056 13,436 0.7% All infants (< 1 year) 0.011079 8,557 1.2% Nursing infants 0. 004345 21,817 0.5% Non - nursing infants 0.013634 6,953 1.4% Children 1 - 6 yrs 0.008929 10,617 0.9% Children 7 - 12 yrs 0.004649 20,394 0.5% Females 13 - 19 (not preg or nursing) 0.003240 29,256 0.3% Females 20+ (not preg or nursing) 0.004777 19,844 0.5% Females 13 - 50 yrs 0.004422 21,440 0.5% Females 13+ (preg/not nursing) 0.003590 26,403 0.4% Females 13+ (nursing) 0.005594 16,945 0.6% Males 13 - 19 yrs 0.003526 26,884 0.4% Males 20+ yrs 0.004303 22,034 0.5% Seniors 55+ 0.004900 19,347 0.5% Children 1 - 2 yrs 0.010749 8,819 1.1% Children 3 - 5 yrs 0.008556 11,081 0.9% Children 6 - 12 yrs 0.004916 19,283 0.5% Youth 13 - 19 yrs 0.003393 27,936 0.4%Cy azofamid Dietary Exposure Assessment DP Number: 343442 PC Code: 085651

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Page 13 of 16 Adults 20 - 49 yrs 0.004351 21,789 0. 5% Adults 50+ yrs 0.004884 19,411 0.5% Females 13 - 49 yrs 0.004302 22,034 0.5%

-----------------------------------------------------------------------------Cy azofamid Dietary Exposure Assessment DP Number: 343442 PC Code: 085651

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## Acute Food + Drinking Water Input File U.S. Environmental Protection Agency Ver. 2.02 DEEM - FCID Acute analysis for CYAZOFAMID Residue file name: C: \ Documents and Settings \ aacierto \ Desktop \ DEEM - FCID Files \ DEEM2010 \ acute cyazofamid food+water.R98 Analysis Date 03 - 16 - 2010 Residue file dated: 03 - 16 - 2010/13:34:40/8 Reference dose: aRfD = 1 mg/kg bw/day NOEL = 100 mg/kg bw/day Comment: Drinking Water using CTCA Drinking Water estimate (scenario #3)

---- ------------------------------------------------------------------------ EPA Crop Def Res Adj.Factors Comment Code Grp Food Name (ppm) #1 #2

-------- ---- -------------- ----------------- ---------- ------ ------ ---

---- 09020210 9B Balsam pear 0.100000 1.000 1.000 05010610 5A Broccoli 1.200000 1.000 1.000 05010611 5A Broccoli - babyfood 1.20000 0 1.000 1.000 05010620 5A Broccoli, Chinese 1.200000 1.000 1.000 05020630 5B Broccoli raab 12.000000 1.000 1.000 05010640 5A Brussels sprouts 1.200000 1.000 1.000 05010690 5A Cabbag e 1.200000 1.000 1.000 05020700 5B Cabbage, Chinese, bok choy 12.000000 1.000 1.000 05010710 5A Cabbage, Chinese, napa 1.200000 1.000 1.000 05010720 5A Cabbage, Chinese, mustard 1.200000 1.000 1.000 09010750 9A Cantaloupe 0.100000 1.000 1.000 01010780 1AB Carrot 0.090000 1.000 1.000 01010781 1AB Carrot - babyfood 0.090000 1.000 1.000 09010800 9A Casaba 0.100000 1.000 1.000 05010830 5A Cauliflower 1.200000 1.000 1.000 09020880 9B Chayote, fruit 0.100000 1.000 1.000 09021020 9B Chinese waxgourd 0.100000 1.000 1.000 05021170 5B Collards 12.000000 1.000 1.000 09021350 9B Cucumber 0.100000 1.000 1.000 08001480 8 Eggplant 0.400000 1.000 1.000 95001750 O Grape 1.500000 1.000 1.000 95001760 O Grape, juice 1.500000 1.000 1.000 95001761 O Grape, juice - babyfood 1.500000 1.000 1.000 95001770 O Grape, leaves 1.500000 1.000 1.000 95001780 O Grape, raisin 1.500000 1.000 1.000 95001790 O Grape, wine and sherry 1.500000 1.000 1.000 09011870 9A Honeydew melon 0.100000 1.000 1.000 95001880 O Hop 10.000000 1.000 1.000 05021940 5B Kale 12.000000 1.000 1.000 05011960 5A Kohlrabi 1.200000 1.000 1.000 05022290 5B Mustard greens 12.000000 1.000 1.000 08002340 8 Okra 0.400000 1.000 1.000 08002700 8 Pepper, bell 0.400000 1.000 1.000 08002701 8 Pepper, bell - babyfood 0.400000 1.000 1.000 08002710 8 Pepper, be ll, dried 0.400000 1.000 1.000 08002711 8 Pepper, bell, dried - babyfood 0.400000 1.000 1.000 08002720 8 Pepper, nonbell 0.400000 1.000 1.000 08002721 8 Pepper, nonbell - babyfood 0.400000 1 .000 1.000 08002730 8 Pepper, nonbell, dried 0.400000 1.000 1.000 01032960 1C Potato, chips 0.020000 1.000 1.000 01032970 1C Potato, dry (granules/ flakes) 0.020000 1.000 1.000Cy azofamid Dietary Exposure Assessment DP Number: 343442 PC Code: 085651

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Page 15 of 16 01032971 1C Potato, dry (granules/ flakes)
- b 0.020000 1.000 1.000 01032980 1C Potato, flour 0.020000 1.000 1.000 01032981 1C Potato, flour - babyfood 0.020000 1.000 1.000 01032990 1C Potato, tuber, w/peel 0.020000 1. 000 1.000 01032991 1C Potato, tuber, w/peel
- babyfood 0.020000 1.000 1.000 01033000 1C Potato, tuber, w/o peel 0.020000 1.000 1.000 01033001 1C Potato, tuber, w/o peel
- babyfood 0.020000 1.000 1.000 09023080 9B Pumpkin 0.100000 1.000 1.000 09023090 9B Pumpkin, seed 0.100000 1.000 1.000 05023180 5B Rape greens 12.000000 1.000 1.000 04013550 4A Spinach 9.000000 1.0 00 1.000 09023560 9B Squash, summer 0.100000 1.000 1.000 09023561 9B Squash, summer - babyfood 0.100000 1.000 1.000 09023570 9B Squash, winter 0.100000 1.000 1.000 09023571 9B Squash, winte r - babyfood 0.100000 1.000 1.000 08003740 8 Tomatillo 0.400000 1.000 1.000 08003750 8 Tomato 0.400000 1.000 1.000 08003751 8 Tomato - babyfood 0.400000 1.00 0 1.000 08003760 8 Tomato, paste 0.400000 1.000 1.000 08003761 8 Tomato, paste - babyfood 0.400000 1.000 1.000 08003770 8 Tomato, puree 0.400000 1.000 1.000 08003771 8 Tomato, puree - babyfood 0.400000 1.000 1.000 08003780 8 Tomato, dried 0.400000 1.000 1.000 08003781 8 Tomato, dried - babyfood 0.400000 1.000 1.000 08003790 8 Tomato, juice 0.400000 1.000 1.000 95003800 O Tomato, Tree 0.200000 1.000 1.000 05023890 5B Turnip, greens 12.000000 1.000 1.000 86010000 O Water, direct, all sources 0.136000 1.000 1.000 86020000 O Water, indirect, all sources 0.136000 1.000 1.000 09013990 9A Watermelon 0.100000 1.000 1.000 09014000 9A Watermelon, juice 0.100000 1.000 1.000Cy azofamid Dietary Exposure Assessment DP Number: 343442 PC Code: 085651

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## Acute Food + Drinking Water Results File U.S. Environmental Protection Agency Ver. 2.02 DEEM - FCID ACUTE Analysis for CYAZOFAMID (1994 - 98 data) Residue file: a cute cyazofamid food+water.R98 Adjustment factor #2 NOT used. Analysis Date: 03 - 16 - 2010/13:37:03 Residue file dated: 03
- 16 - 2010/13:34:40/8 NOEL (Acute) = 100.000000 mg/kg body
- wt/day Daily totals for food and foodform consumption used. Run Comment: "Drinking Water using CTCA Drinking Water estimate (scenario # 3)"

============================================================================= Summary calculations (per capita): 95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE

---------- ------- -------- ---------- ------- -------- ---------- ---------- U.S. Population: 0.014299 1.43 6993 0.031974 3.20 3127 0.071845 7.18 1391 Females 13 - 49 yrs: 0.012139 1.21 8237 0.024480 2.45 4085 0.059739 5.97 1673